Aligning mRNA Progress with Regulatory Streamlining
MIT Researchers Identify Compounds that Fight Viral Infections
Scientists at MIT and other institutions have discovered compounds that activate a defense pathway inside host cells that could be used as antiviral drugs.
GSK Seeks Expanded Use Approval from FDA for RSV Vaccine Arexvy
FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.
LEO Pharma Takes Over Global Development of Spevigo for Rare Skin Disease GPP
The IL-36 inhibitor is being explored for additional inflammatory skin conditions, aiming to expand treatment options for underserved patient groups.
Cellular Origins, Cell and Gene Therapy Catapult, and Resolution Therapeutics Form CGT Manufacturing Consortium
The consortium will focus on the delivery of a fully automated robotics cell and gene therapy manufacturing platform.
Junevity's Bold Move: Using siRNA to Fight Diabetes and Obesity
Two Celltrion Denosumab Biosimilars Now Available in US
Stoboclo and Osenvelt (both denosumab-bmwo) reference Amgen’s Prolia and Xgeva, respectively.
Circio Expanding R&D in Sweden for Acceleration of Next-Gen Therapeutics
Increased capacity will help Circio progress development of circVec AAV gene therapy and in-vivo cell therapy, with the company setting a goal of selecting its first therapeutic candidate in 2026.
Two Biocon Biologics Denosumab Biosimilars Approved by MHRA
Biocon said that, according to clinical data, both Vevzuo and Evfraxy demonstrated a safety and efficacy profile comparable to that of the reference product.
9 Implications of Trump’s Tax-Cut and Spending Bill for the Bio/Pharmaceutical Industry
Trump’s tax bill could reshape drug R&D, manufacturing, Medicaid access, clinical trials, and biotech funding, impacting strategy across the bio/pharmaceutical industry.
Modeling Approaches for Determination of Pharmacokinetics/Pharmacodynamics
Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.
Optimizing Downstream Processes for Biotherapeutic Development with Prepacked Chromatography Columns
As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.
5 Ways mRNA Is Revolutionizing Drug Development Beyond Vaccines
Once limited to experimental vaccine platforms, messenger RNA (mRNA) is now taking center stage across the entire biotech landscape.
Multiple Myeloma Treatment from Regeneron Gets FDA Accelerated Approval
Linvoseltamab-gcpt, marketed as Lynozyfic, is a bispecific antibody designed to facilitate T cell activation and cancer cell killing.
Piramal Pharma Breaks Ground on Kentucky Facility, Part of $90 Million Expansion Plan
The expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.
Simtra Completes Construction of New Production Facility in Germany
The new building will create 150 new jobs and expands total production area to nearly 12,000 square meters.